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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Tricot Jumpsuit crotch zipper 1011 — Class I MDR

MD Atlas
4Care Nederland B.V.

EUDAMED last updated this device on May 1, 2026

Tricot Jumpsuit crotch zipper 1011

40517081011J5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: 4Care Nederland B.V.
UDI-DI code: 04051708000560
Reference / catalog number: 1011.201.XS

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View device family (Basic UDI)

Manufacturer information

Organization name: 4Care Nederland B.V.
SRN: NL-MF-000050317
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: Tricot Jumpsuit crotch zipper 1011
UDI-DI code: 04051708000560
Basic UDI-DI: 40517081011J5
Reference / catalog number: 1011.201.XS
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: This comfortable and discrete long sleeve full length footless tricot jumpsuit with back zipper closure and extra zipper closure on the inside leg seam is perfect for those who use incontinence products. The leg zipper closure makes diaper removal and changes very convenient for the carers but difficult for the patient
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04051708000560

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.